BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2131181 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10437
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RECEIVED IN SEGMENTS. THE DISTAL CONDUCTOR APPEARED FRACTURED. BLOOD/BODY FLUID WAS FOUND ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), AND BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE MECHANISM (SLEEVE HEAD). THE INNER TUBING WAS KINKED/BUCKLED, AND THE HELIX/LOBE WAS DISTORTED/BENT. THE OUTER INSULATION WAS TORN, BREACHED CUT, AND EXHIBITED COSMETIC DEPRESSION. A WHITE SUBSTANCE WAS FOUND ON THE OUTER INSULATION AND THE EXPOSED DEFIB COIL. THE LEAD APPEARED FLEXED WITHIN 5CM OF THE ANCHORING SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHOWED SOME SHORT V-V INTERVALS POSSIBLY DUE TO NOISE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB